Soluble needle for hair transplantation and manufacture method thereof

ABSTRACT

A soluble needle (100) for hair transplantation, wherein the soluble needle (100) comprises a fixing plate (30) and a plurality of micro-needles (20) made of water-soluble polymers arranged on the fixing plate (30), wherein each of said micro-needle (20) comprises a needle wall (21) to penetrate scalps and a needle cavity (22) confined by the needle wall (21) and configured for accommodating a hair follicle. A method of manufacturing a soluble needle (100) for hair transplantation, wherein the method includes: dissolving water-soluble polymers in water to prepare a molding solution (S101); delivering the molding solution into a mold (S102); letting the molding solution settle in the mold to shape (S103); and separating and removing the mold to produce the soluble needle (S104). The soluble needle (100) effectively shortens the time of surgery, reduces the pain of the patients, and increases the viability rate of transplanted hair follicles.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to Chinese Patent ApplicationNo. 2017107335902, entitled “Soluble needle for hair transplantation andmanufacture method thereof” and filed with Chinese patent office on Aug.24, 2017, the entire contents of which are incorporated herein byreference.

FIELD OF THE INVENTION

The present disclosure relates to the technical field of hairtransplantation devices, in particular to a soluble needle for hairtransplantation and a method of manufacturing the same.

BACKGROUND

Many people suffer from hair loss due to age, genetics, and otherfactors, and now this problem could be solved by hair transplantationtechnologies. The common method of hair transplantation comprisesextracting hair follicles from the back of the head of a human assources of hairs, with the hair sources separated as single or multiplehair follicular units, directly transplanting the separated hairfollicular units to the receiving sites on human bodies (e.g. scalps,eyebrow, lower jaws, chests, eyelids, pubic areas etc.) by precisemicrosurgeries, to make the transplanted hair follicular units surviveat the new sites and naturally grow, so as to modify and increase thedistribution and density of the hairs at local areas.

In the prior hair transplantation microsurgeries, small holes areusually created firstly by puncturing the scalp with 18G or 19G needles,and subsequently hair follicles are picked up from the root anddelivered into the resulted holes by small tweezers. Since usually alarge number of hair follicles are required for the hair transplantationsurgery, the hair transplantation surgery process is tedious andtime-consuming, and the repeated process of scalp puncturing introducesgreat pain to the patient. Furthermore, the microsurgery requiresprecise operations under microscope for a long time, and misoperationscould easily cause damage to the hair follicles, resulting in hairfollicles failing to grow well, affecting the viability rate oftransplanted hair follicles.

SUMMARY OF THE INVENTION

In view of this, the present disclosure aims to provide a soluble needlefor hair transplantation and a method of making the same, wherein theuse of the soluble needle for hair transplantation of the presentdisclosure can provide a higher viability rate of transplanted hairfollicles, a better hair transplantation effect, a more convenient hairtransplantation process, and a shorter surgery time.

One aspect of the embodiments of the present disclosure provides asoluble needle for hair transplantation, comprising: a fixing plate anda plurality of micro-needles made of water-soluble polymers and arrangedon the fixing plate, said micro-needles each comprising a needle wall topenetrate a scalp, and a needle cavity confined by the needle wall andconfigured for accommodating a hair follicle.

Optionally, said micro-needle is made of hyaluronic acid or polyvinylalcohol.

Optionally, the needle walls of said plurality of micro-needles areconnected to each other; or, the needle walls of said plurality ofmicro-needles are connected to each other through a connecting layer,and the connecting layer is made of the same material as themicro-needles.

Optionally, said plurality of micro-needles are evenly arranged on thefixing plate.

Optionally, said plurality of micro-needles are arranged at a density of20 to 40 needles/cm² on the fixing plate.

Optionally, said plurality of micro-needles are tapered in structure.

Optionally, the tip of the micro-needle is provided with a pinholerunning through the needle wall and communicating with the needlecavity.

Optionally, the micro-needle is in a conical structure, the apex angleof the micro-needle is between 15° and 20°, and the diameter of thebottom surface of the micro-needle is between 2.2 mm and 2.8 mm.

Optionally, the thickness of the needle wall is between 0.8 mm and 1.2mm.

Optionally, said fixing plate is a fixing film layer, and the fixingfilm layer is configured to be attached by the micro-needles.

Optionally, said plurality of micro-needles are each fixedly connectedto said fixing plate through one side of the needle cavity, and thefixing plate is made of the same material as the micro-needles.

Optionally, the fixing plate and the micro-needles are detachablyconnected to each other.

Another aspect of the embodiments of the present disclosure provides amethod for manufacturing a soluble needle for hair transplantation,comprising:

dissolving the water-soluble polymers in water to prepare a moldingsolution;

delivering the molding solution into a mold;

letting the molding solution settle in the mold to shape; and

separating and removing the mold to produce the soluble needle.

Optionally, the mass fraction of the molding solution is 15 to 25 wt %.

Optionally, said letting the molding solution settle in the mold toshape includes letting the molding solution settle statically in themold at an ambient temperature of 25° C. to 70 ° C., for a settling timeof 3 h-24 h.

Optionally, said method includes performing degassing treatment on themolding solution before letting the molding solution settle in the moldto shape.

Optionally, delivering the molding solution into a mold includes:

injecting the molding solution into the mold, wherein the mold includesa plurality of mold cavities corresponding to said plurality ofmicro-needles, and the volume of molding solution injected into eachmold cavity is less than the capacity of the mold cavity, so as to forma needle cavity in the to-be-molded micro-needle structure in each moldcavity.

Optionally, said letting the molding solution settle in the mold toshape includes creating a through hole for each to-be-moldedmicro-needle structure in each mold cavity, so as to form a pinhole atthe tip of the each to-be-molded micro-needle structure, with thepinhole communicating with the needle cavity.

Embodiments of the present disclosure provide a soluble needle for hairtransplantation and a method of making the same, the soluble needlecomprising a fixing plate and a plurality of micro-needles made ofwater-soluble polymers and arranged on the fixing plate, saidmicro-needles each comprising a needle wall to penetrate the scalp and aneedle cavity confined by the needle wall and configured foraccommodating a hair follicle. When applying the soluble needles in theembodiments of the present disclosure in the hair transplantationsurgery, the hair follicles to be transplanted are transferred into theneedle cavities of the micro-needles in advance, and during the surgerythe micro-needle portions of the soluble needles for hairtransplantation are inserted into the dermis of the scalp and remain inthe sites of the scalp. As the water-soluble polymers of themicro-needles are gradually dissolved in blood or sweat and absorbed bythe human body, the hair follicles accommodated in the needle cavitiescome into contact with the blood in the dermis and become viable andstart to grow. This process effectively shortens the time of surgery,reduces the pain of the patients, and increases the viability rate oftransplanted hair follicles.

For better understanding of the purposes, features, and advantages ofthe present disclosure, exemplary embodiments will be described ingreater details in accordance with the accompanying drawings in thefollowing.

BRIEF DESCRIPTION OF THE FIGURES

For clearer description of the technical solutions of the embodiments ofthe present disclosure, the drawings accompanying the embodiments willbe briefly described below. It should be understood that the followingdrawings demonstrate only exemplary embodiments of the presentdisclosure, and should not be considered as limitations on the scope ofthe present disclosure, for those skilled in the art other relateddrawings can be obtained based on the given drawings without anycreative work.

FIG. 1 demonstrates a schematic three-dimensional structure view of asoluble needle in an embodiment of the present disclosure;

FIG. 2 demonstrates a first schematic view showing a plurality ofmicro-needles in an embodiment of the present disclosure;

FIG. 3 demonstrates a cross-sectional view taken along line A-A of FIG.2;

FIG. 4 demonstrates a second schematic view showing a plurality ofmicro-needles in an embodiment of the present disclosure;

FIG. 5 demonstrates a schematic structural diagram of a singlemicro-needle in an embodiment of the present disclosure;

FIG. 6 demonstrates a first flow chart of a method of manufacturing asoluble needle in an embodiment of the present disclosure;

FIG. 7 demonstrates a second flow chart of a method of manufacturing asoluble needle in an embodiment of the present disclosure;

FIG. 8 demonstrates a third flow chart of a method of manufacturing asoluble needle in an embodiment of the present disclosure;

FIG. 9 demonstrates a fourth flow chart of a method of manufacturing asoluble needle in an embodiment of the present disclosure;

FIG. 10 demonstrates a fifth flow chart of a method of manufacturing asoluble needle in an embodiment of the present disclosure;

Reference numbers: 100—soluble needle; 20—micro-needle; 21—needle wall;22—needle cavity; 23—connecting layer; 24—pinhole; 30—fixing plate.

DETAILED DESCRIPTION OF THE INVENTION

For better illustration of the purposes, technical solutions, andadvantages of the present disclosure, the technical solutions in theembodiments of the present disclosure will hereinafter be clearly andcomprehensively described in combination with the drawings of theembodiments of the present disclosure. Obviously, the embodimentsdescribed herein are only preferred embodiments and are not all possibleembodiments of the present disclosure. The components of the disclosedembodiments, which are described and illustrated in the drawings herein,may generally be arranged and designed in various alternativeconfigurations.

Therefore, the detailed description of the embodiments of the presentdisclosure herein, should not be considered as limitations on the scopeof the present disclosure, but merely examples of selected embodimentsof the present disclosure. Any other embodiments which those skilled inthe art can obtain without any creative work based on the embodiments ofthe present disclosure herein should all fall within the scope of thepresent disclosure.

It should be noted that similar symbols and letters represent similarelements in the drawings hereinafter. Therefore, once an element isdefined in one drawing, no further definition or explanation is neededfor the same element in subsequent drawings. In the descriptions of thepresent disclosure, it should be understood that, the terms“longitudinal”, “transversal”, “on”, “under”, “in front of”, “behind”,“left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”,“outside”, etc. that indicate the directions or positions based on thedirections or positions shown in the drawings or the directions orpositions in which the inventive product is commonly placed, are onlyfor the purpose of describing the present disclosure and simplifying thedescriptions, but not intended to indicate or imply that a device or acomponent has a compulsory position or must be structured or operated ina specific position, hence not to be considered as limitations to thepresent disclosure.

In this description, the illustrative expressions with the above termsare not necessarily referring to the same embodiments or examples. Inaddition, specific features, structures, materials, or characteristicsdescribed may be combined in appropriate manners in any one or moreembodiments or examples.

In addition, terms “first”, “second”, etc. are for description purposesonly and should not be considered to be indicating or implyingimportance in relativity or implicitly indicating the number of thetechnical features referred to. Therefore, features determined by“first”, “second”, etc. may explicitly or implicitly contain one or moreof the same features. In the description of present disclosure, “aplurality of” means two or more, unless otherwise specified.

In the description of present disclosure, it should be noted that terms“arrange”, “attach”, “connect” should be perceived with generalizedmeanings, for instance, “connect” could mean to mechanically connect orelectrically connect, to connect internally between two components, toconnect directly, or to connect through media. Those skilled in the artshould be able to perceive the specific meanings of the above terms baseon specific context.

The present disclosure will be further described in detail according tothe specific embodiments in combination with drawings.

An embodiment of the present disclosure provides a soluble needle 100for hair transplantation, as shown in FIG. 1, comprising: a fixing plate30, and a plurality of micro-needles 20 made of water-soluble polymersand arranged on the fixing plate 30, said micro-needles 20 eachcomprising a needle wall 21 to penetrate the scalp and a needle cavity22 confined by the needle wall 21 and configured for accommodating thehair follicle, as shown in FIG. 3.

It should be noted that firstly, when manufacturing the soluble needle100 for hair transplantation in this embodiment of the presentdisclosure, the hair follicles to be transplanted are transferred intothe needle cavities 22 of the micro-needles 20 in advance, so that inthe surgery using the soluble needles 100 for hair transplantation, thesoluble needles 100 are attached to the scalp on the side wheremicro-needles 20 are configured, and the needle portions of themicro-needles 20 penetrate deeply into the dermis of the scalp. As thewater-soluble polymers of the micro-needles 20 start to dissolvegradually in blood or sweat and to be absorbed gradually by the humanbody, the hair follicles accommodated in the needle cavities 22 comeinto contact with the blood in the dermis and become viable and grow,during which process no human intervention or other operations arenecessary, providing a stable environment for the hair follicles tosurvive and grow at the new sites.

Secondly, this embodiment of the present disclosure does not setlimitations to the shape and material of the fixing plate. Generally,the micro-needles 20 are arranged on the fixing plate 30 in a densemanner so as to improve the efficiency of the surgery. Illustratively,as shown in FIG. 1, the fixing plate 30 is of rectangular shape. As oneexample, when the fixing plate 30 is made of the same water-solublepolymer as the micro-needles 20, the fixing plate 30 can dissolvegradually as the micro-needles 20 dissolve and can then be wiped away bysoft tissues or clothes, after the soluble needles 100 are attached tothe scalp and the micro-needles 20 penetrate deeply into the dermis ofthe scalp. As another example, when the fixing plate 30 is made of othernon-soluble material, the fixing plate 30 can be removed after themicro-needles 20 are dissolved and absorbed by human body and the hairfollicles become viable and start to grow in the dermis of the scalp.

Thirdly, a water-soluble polymer is also called a water-soluble resin.It is a highly hydrophilic polymeric material that dissolves or swellsin water to form an aqueous solution or dispersion system. There is alarge amount of hydrophilic groups in the molecular structure of thewater-soluble polymer. There may be three types of hydrophilic groups: 1cationic groups, such as tertiary amine group, quaternary amine group,etc.; 2 anionic groups, such as carboxylic acid group, sulfonic acidgroup, phosphoric acid group, sulfuric acid group, etc.; 3 polarnonionic groups, such as hydroxyl group, ether group, amine group, amidegroup, etc. The water-soluble polymer materials for manufacturing themicro-needles 20 in the embodiment of the present disclosure may benatural water-soluble polymers from natural animals and plants sources,such as starch, cellulose, vegetable gums, animal gels, etc.; chemicallymodified natural polymers, such as carboxymethyl starch, starch acetate,hydroxymethyl cellulose, carboxymethyl cellulose, etc.; or syntheticpolymers (including polymerization resin and condensation resin), suchas polyacrylamide (PAM), hydrolyzed polyacrylamide (HPAM), polyvinylpyrrolidone (PVP). The water-soluble polymers may also be divided intonon-ionic polymers and ionic polymers based on the hydration groups onthe macromolecular chains. The water-soluble polymers may also bedivided into nonionic polymers, cationic polymers, anionic polymers, andzwitterionic polymers (latter three being polyelectrolytes) based onelectric charges. The water-soluble polymers may also be divided intoassociated polymers and non-associated polymers based on whether thereare strong non-covalent bonds between the groups. This embodiment of thepresent disclosure does not set limitations to the above-mentioned typesof the water-soluble polymer. Any water-soluble polymer that candissolve and be absorbed when puncture into human skin falls within thescope.

Fourthly, this embodiment of the present disclosure does not setlimitations to the shape of the micro-needles 20. The micro-needles 20only need to be able to penetrate the scalp with the needle walls 21 andenter the dermis of the scalp so that the hair follicles accommodated inthe needle cavities 22 can come into contact with the dermis and becomeviable and grow. Accordingly, this embodiment of the present disclosuredoes not set limitations to the shape and size of the needle cavities22. Since the purpose of the needle cavities 22 is to accommodate thehair follicles, the needle cavities 22 only need to be able toaccommodate hair follicles and be able to expose the hair follicles tothe dermis when the micro-needles 20 dissolve so that the hair folliclescould become viable and start to grow.

The embodiment of the present disclosure provides a soluble needle 100for hair transplantation, comprising: a fixing plate 30 and a pluralityof micro-needles 20 made of water-soluble polymers arranged on thefixing plate 30, said micro-needles 20 each comprising a needle wall 21to penetrate the scalp and a needle cavity 22 confined by the needlewall 21 and configured for accommodating the hair follicles. Whenapplying the soluble needle 100 in this embodiment of the presentdisclosure in the hair transplantation surgery, the hair follicles to betransplanted are transferred into the needle cavities 22 of themicro-needles 20 in advance. During the surgery the micro-needles 20 ofthe soluble needle 100 are aimed at the scalp and the micro-needles 20penetrate the scalp and enter the dermis of the scalp with the remainingof the soluble needle 100 left on the scalp. As the water-solublepolymers of the micro-needles 20 dissolve in blood or sweat and to beabsorbed by the human body gradually, the hair follicles accommodated inthe needle cavities 22 come into contact with the blood in the dermisand become viable and start to grow. This process effectively shortensthe time of surgery, reduces the pain of the patients, and increases theviability rate of transplanted hair follicles.

Optionally, the micro-needles 20 are made of hyaluronic acid orpolyvinyl alcohol.

The water-soluble polymer may include any one of hyaluronic acid orpolyvinyl alcohol, and may also include other biodegradable polymers.Hyaluronic acid is a higher polysaccharide consisting of units ofD-glucuronic acid and N-acetylglucosamine. D-glucuronic acid andN-acetylglucosamine are linked by a β-1,3 -glycosidic bonds, and thedisaccharide units are linked by a β-1,4 -glycosidic bonds. Number ofthe disaccharide units can be up to 25000. The molecular weight ofhyaluronic acid in human body ranges from 5,000 to 20,000,000 Dalton,with a general molecular formula (C₁₄H₂₁NO₁₁)n.

As one example, in this embodiment of the present disclosure, themicro-needles 20 are made of hyaluronic acid. Hyaluronic acid canimprove skin growth conditions. Specifically, hyaluronic acid can form abreathable film on the skin surface to make the skin smooth and moist,and prevent the invasion of foreign bacteria, dust, and ultravioletlight, hence to protect the skin from damages. Hyaluronic acid can alsoinfiltrate into the dermis, providing functions of slight expansion ofcapillaries, blood circulation improvement, intermediate metabolismimprovement, and accelerated skin nutrient absorption, and has a strongwrinkle-reducing effect, which can increase elasticity of skin and delayageing. Hyaluronic acid can further promote the proliferation anddifferentiation of epidermal cells, get rid of free oxygen radicals, andprevent and repair skin damage. The aqueous solution of hyaluronic acidis highly viscous, which can thicken aqueous phase or stabilize theemulsion, which achieves uniform and fine paste after emulsified withoil phase.

As another example, the micro-needles 20 can also be made of polyvinylalcohol (PVA). PVA has a general molecular formula of

In this embodiment of the present disclosure, PVA is preferably selectedto be medical grade PVA, e.g. EG-05P, EG-05, EG-40, etc. Specifically,PVA may be PVA 0588 or PVA 1788.

Optionally, as shown in FIG. 2, the needle walls 21 of a plurality ofthe micro-needles 20 are connected to each other; or, as shown in FIG.4, the needle walls 21 of a plurality of the micro-needles 20 areconnected to each other through a connecting layer 23, and theconnecting layer 23 is made of the same material as the micro-needles20.

As one example, shown in FIG. 2, the needle walls 21 of a plurality ofthe micro-needles 20 are connected to each other, so that a plurality ofthe micro-needles 20 form a unity and may connect with the fixing plate30. As a result, when the micro-needles 20 are arranged on the fixingplate 30, a plurality of micro-needles 20 connected to each other can bearranged onto the fixing plate 30 as a unity, rather than to tediouslyarrange individual micro-needles 20 one by one, and therefore couldimprove the speed and efficiency of arrangement for the plurality ofmicro-needles 20 onto the fixing plate 30.

As another example, as shown in FIG. 4, when the micro-needles 20 arearranged on the fixing plate 30 (not shown in FIG. 4, see FIG. 1) in aless dense manner, the needle walls 21 of every two neighboringmicro-needles 20 are connected by a connecting layer 23, wherein theconnecting layer 23 is made of the same material as the micro-needles20. As a result, as the micro-needles 20 dissolve in blood or sweat andto be absorbed gradually after penetrate the scalp and enter the dermisof the scalp, the connecting layer 23 also dissolves gradually, and thedissolved connecting layer 23 could be wiped away by soft tissues orclothes, so that, when manufacturing the soluble needle 100 in thisembodiment of the present disclosure, a plurality of micro-needles 20connected by the connecting layer 23 could be arranged as a unity,improving the speed and efficiency of arrangement for the plurality ofmicro-needles 20 onto the fixing plate 30, and that, after the hairtransplantation surgery using the soluble needle 100 in this embodimentof the present disclosure, a step of removing the connecting layer 23 isnot needed.

Optionally, as shown in FIG. 1, a plurality of micro-needles 20 areevenly arranged on the fixing plate 30.

Illustratively, the micro-needles 20 are evenly arranged on the fixingplate 30, wherein the specific manner of arrangement is transversal andlongitudinal. Herein transversal and longitudinal arrangement meansarrangement as a matrix with rows and columns. As an example,micro-needles 20 can be arranged in 30 rows and 30 columns. When thehair follicles accommodated in the evenly arranged micro-needles 20 aretransplanted to and grow in the scalp, they will have an even andnatural distribution.

Optionally, a plurality of micro-needles 20 are arranged at a density of20 to 40 needles/cm² on the fixing plate 30.

Since the hair follicles in the human scalp grow following certainnatural laws, too high a density of the transplanted hair follicleswould result in a low viability rate of the hair follicles, and too lowa density of the transplanted hair follicles would affect the visualeffect of the transplanted hairs. Therefore, micro-needles 20 arearranged at a density of 20 to 40 needles/cm² on the fixing plate 30. Asan example, the number of micro-needles 20 arranged evenly on everysquare centimeter of the fixing plate 30 is between 20 and 40, e.g. 20,22, 25, 30, 35, 38, 40, etc.

The micro-needles 20 are configured in tapered structure, so thatfirstly it facilitates the needle cavities to form as the bottom of thetapered structure, and secondly the sharp tips of the tapered structurefacilitate the micro-needles 20 to penetrate the scalp and enter thedermis in the hair transplantation surgery.

Optionally, as shown in FIG. 1, the micro-needles 20 are tapered instructure. The micro-needles 20 are configured in tapered structure, sothat firstly it facilitates the formation of the needle cavities in thebottom of the tapered structure, and secondly the sharp tips of thetapered structure facilitate the micro-needles 20 to penetrate the scalpand enter the dermis in the hair transplantation surgery.

Optionally, as shown in FIG. 5, the tip of the micro-needle 20 isprovided with a pinhole 24 running through the needle wall 21 andcommunicating with the needle cavity 22.

As a result, when the soluble needle 100 in this embodiment of thepresent disclosure is applied in hair transplantation surgery and themicro-needles 20 penetrate the scalp and enter the dermis of the scalp,due to the pinhole 24 provided on the tip being communicating with theneedle cavity 22, the hair follicles accommodated in the needle cavities22 are able to be exposed to the blood and start to grow even before themicro-needles 20 start to dissolve, so that the hair follicles will haveearlier contact with the human body and therefore the viability rate ofthe transplanted hair follicles will be improved.

Optionally, as shown in FIG. 1, the micro-needles 20 have a conicalstructure, the apex angle of the micro-needle 20 is between 15° and 20°,and the diameter of the bottom surface of the micro-needle 20 is between2.2 mm and 2.8 mm.

Illustratively, in the embodiment wherein the micro-needles 20 are ofconical structure, the apex angle of the micro-needle 20 can beconfigured between 15° and 20°, e.g. 15°, 16°, 17.06°, 19°, 19.5°, 20°,etc. When the apex angle is larger than 20°, the conical structure mayhave too large an apex angle, resulting in a relatively large bottomsurface area of the micro-needle 20 if keeping other parametersunchanged, and therefore causing difficulties in arranging themicro-needles 20 at a relatively high density on the fixing plate 30.When the apex angle is smaller than 15°, the volume of the needle cavity22 of the micro-needle 20 may be too small to accommodate the hairfollicle. Moreover, the diameter of the bottom surface of themicro-needle 20 is configured between 2.2 mm and 2.8 mm, e.g. 2.2 mm,2.25 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.8 mm, etc. As a result, provided thatthere is sufficiently large volume of the needle cavity 22, individualmicro-needles 20 is prevented from occupying too large area on thefixing plate 30 and leading to insufficiently dense arrangement ofmicro-needles 20 on the fixing plate 30.

Optionally, the thickness of the needle wall 21 is between 0.8 mm and1.2 mm, e.g. 0.8 mm, 0.85 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, etc. As aresult, provided that the needle wall 21 is stiff enough to penetratethe scalp and enter the dermis, the thickness of the needle wall 21 isconfigured as small as possible, so as to prevent the needle wall 21 ofthe micro-needle 20 being too thick and hence the time for thewater-soluble polymer to dissolve being too long.

In addition, the height of the micro-needles 20 may be configuredbetween 6.5 mm and 7.5 mm, e.g. 6.5 mm, 6.52 mm, 6.6 mm, 6.8 mm, 7 mm,7.2 mm, 7.4 mm, or 7.5 mm, etc. The micro-needles 20 with height in thisrange would be easy to penetrate the scalp and enter the dermis, withoutfurther damaging the scalp of the patient.

In addition, the needle cavity 22 may also be configured to have aconical structure. The apex angle of the needle cavity 22 mayaccordingly be configured between 15° and 20°, e.g. 15°, 16°, 17.06°,19°, 19.5°, or 20°, etc. The diameter of the bottom surface of theneedle cavity 22 may accordingly be configured between 1.2 mm and 1.8mm, e.g. 1.2 mm, 1.25 mm, 1.3 mm, 1.4 mm, 1.5 mm, or 1.8 mm, etc. Theheight of the needle cavity 22 may accordingly be configured between 3.5mm and 5.5 mm, e.g. 3.5 mm, 3.52 mm, 3.6 mm, 3.8 mm, 4 mm, 4.2 mm, 4.4mm, or 4.5 mm, etc.

Optionally, the fixing plate 30 is a fixing film, and the fixing film isconfigured to be attached to the micro-needles 20.

The fixing plate 30 is a fixing film, which has certain flexibility andelasticity, and is configured to be attached to the micro-needles 20. Asa result, when applying the soluble needle 100 in this embodiment of thepresent disclosure in the hair transplantation surgery on the patient'sscalp, pressing forces could be more conveniently and evenly applied tothe scalp, improving the result of transplantation of the hairfollicles. In addition, a fixing film is easier to be removed after thehair follicles accommodated in the cavity 22 become viable in the scalp.

Optionally, as shown in FIG. 1, a plurality of micro-needles 20 areconfigured to be fixed to the fixing plate 30 on the side of the needlecavities 22, and the fixing plate 30 is made of the same material as themicro-needles 20.

As a result, since the fixing plate 30 is made of the same material asthe micro-needles 20, which means that the fixing plate 30 is also madeof water-soluble polymers, one only needs to wipe away the dissolvedfixing plate 30 with soft tissues or clothes when it graduallydissolves, rather than having to remove the fixing plate 30 fixedlyconnected to the micro-needles 20. The hair follicles are transferredbetween the fixing plate 30 and the needle cavities 22 of themicro-needles 20 in advance, after the micro-needles 20 of the solubleneedle 100 penetrate the scalp and enter the dermis, the soluble needle100 will entirely remain on the scalp of the patient. As thewater-soluble polymers of the micro-needles 20 start to dissolve and tobe absorbed by the human body gradually, the hair follicles becomeviable in the dermis and start to grow. Since the fixing plate 30 ismade of the same water-soluble polymers as the micro-needles 20, oneonly needs to wipe away the dissolved fixing plate 30, rather thanhaving to remove it.

Optionally, the fixing plate 30 and the micro-needles 20 are detachablyconnected.

In the soluble needle 100 in this embodiment of present disclosure, theneedle cavities 22 may be open cavities so that the hair follicles couldbe delivered into the needle cavities 22 in advance. For example, theneedle cavity 22 may have an open end through which the hair folliclesmay be placed into the needle cavity 22. In one embodiment, as shown inFIG. 5, the micro-needle 20 has an open bottom connecting to the needlecavities 22. In another embodiment, a through hole may be created on thefixing plate 30, connecting to the needle cavity 22.

Alternatively, the needle cavities 22 may be closed cavities. In suchembodiments the fixing plate 30 and the micro-needles 20 are detachablyconnected, so that when the hair follicles needed to be delivered, thefixing plate 30 may be detached from the micro-needles 20 to expose theneedle cavities 22.

Here, the detachable connection could be configured as a boltingconnection or a magnetic connection, wherein said bolting connection ormagnetic connection includes two matching components installed on thefixing plate 30 and the micro-needle 20, respectively.

One embodiment of the bolting connection is illustrated herein.Specifically, the bolting connection comprises a bolt installed on thefirst member of connection and a nut installed on the second member ofconnection, wherein the bolt and the nut are matched to one and another.

The bolting connection comprise connecting units installed on the firstmember of connection and elastic bolt heads on ends of the connectingunits. The nuts are surrounded by elastic fixing rings. The bolt headsare of sphere shapes. The bolt heads are of hollow structures, withblind holes extending from the connecting units to the bolt heads, sothat the bolts on the first member of connection are allowed toelastically deform when compressed.

The bolts can be manufactured by integrated molding together with thefirst member of connection. The nuts present multiple nut holes,dividing the nuts into individual nutting units so that the nuts mayelastically deform under external forces.

The diameter of the bolt heads is larger than that of the nuts. When thebolts bolt into the nuts, the nuts are pressed by the bolts and expandelastically, so as to allow the bolt heads pass through the nut holes.After the bolt heads pass through the nut holes, the nuts and the boltheads all recover to original shapes. The bolt heads are held on theother side of the nut holes by the nuts so as to fix the first andsecond member of connection.

Chamfering is configured at the edges of the nuts so that when detachingthe first member of connection from the second member of connection, thebolt heads are easily withdrawn from the nut holes under externalforces.

Another embodiment of the bolting connection is illustrated herein.Specifically, the bolting connection comprises slot units and boltunits. The slot unit comprises a first slot, a second slot, and a hookbetween the first slot and the second slot, all of which are elastic.

The bolt unit comprises a first bolt, a second bolt, and a gib betweenthe first bolt and the second bolt, all of which are elastic. When thebolt unit is connecting to the slot unit, the first bolt bolts into thefirst slot, the second bolt bolts into the second slot, and the hookconnects with the gib. The elasticity of the first slot, the secondslot, and the gib ensures that they are in close contact with the firstbolt, the second bolt, and the hook, so as to achieve tight connection.

A third embodiment of the bolting connection may be illustrated herein.Specifically, the bolting connection comprises a male member and afemale member, wherein the male member and female member are matching toone and another.

Here, the structures of the male member and the female member are notlimited. Various embodiments of structures may exist, one of them beingsimilar to the buckle applied on school bags.

Specifically, the female member comprises a cavity therein. The malemember is of an E shape, i.e. the male member comprises a first arm, athird arm, and a second arm between the first arm and the third arm. Thefirst arm and the third arm are elastic, and can bend towards the secondarm under external forces. When the external forces are withdrawn, theywill recover to their original positions. The second arm may be elasticor inelastic.

Correspondent to the male member, the front end of the female member iswider than the back end, wherein “front” takes reference to theforwarding position along the direction in which the male member entersthe female member. The width of the front end of the female member isslightly smaller than the width of the male member, and the width of theback end of the female member is remarkably smaller than the width ofthe male member, so that, as the male member enters the female member,the first arm and the third arm are pushed towards the second arm whenmale member reaches the front end of the female member, and when themale member reaches the back end of the female member, the first arm andthe third arm automatically recover to their original positions,extending out of the female member due to the cavity being open.

When connecting the male member and the female member, one could insertthe male member into the female member, at which time the first arm andthe third arm will extend out of the female member; and when detachingthe male member and the female member, one only needs to squeeze thefirst arm and the third arm so that the male member could be withdrawnfrom the female member.

The magnetic connection may comprise electro-magnetic attracting unitsand attracted units. The electro-magnetic attracting units and theattracted units may be installed on the fixing plate 30 and themicro-needles 20 respectively. Here, the electro-magnetic attractingunits may generate attracting force to the attracted units when powered,so as to bring the fixing plate 30 and the micro-needles 20 intoconnection.

As a result, when powered on, the electro-magnetic attracting units maygenerate attracting force to the attracted units, bringing the fixingplate 30 and the micro-needles 20 into connection; when powered off, theattracting force is terminated, and the fixing plate 30 will hencedetach from the micro-needles 20.

Here, the working mechanism of the electro-magnetic attracting units isin the public domain, i.e. an energized conductor (e.g. a coil)generates a magnetic field to attract an object such as metal. Thestructure of the electro-magnetic attracting units may adopt what is inthe public domain, e.g. electro-magnetic chunk or the like. Theattracted units may be iron plates or iron blocks, or objects made ofpermanent magnets, etc.

Optionally, the micro-needles 20 and the fixing plate 30 may bemanufactured by integrated molding, i.e. the micro-needles 20 and thefixing plate 30 are manufactured in the molding in one single processwith the same materials. In addition, pinholes 24 may be created on thetips of the needles walls 21 of the micro-needles 20, communicating withthe needle cavities 22. In embodiments described above, example of themicro-needles 20 and the fixing plate 30 being made of the samematerials has been illustrated in detail, and therefore will not berepeated here.

As shown in FIG. 1, the fixing plate 30 may be square in shape. In suchembodiment, the area of the square fixing plate 30 may be (55 mm˜65mm)×(55 mm˜65 mm), for easy handling and application during surgery.

Another aspect of the embodiments of the present disclosure provides amethod for manufacturing soluble needle 100 for hair transplantation, asshown in FIG. 6, comprising:

S101. dissolving the water-soluble polymers in water to prepare amolding solution;

S102. delivering the molding solution into a mold;

S103. letting the molding solution settle in the mold to shape; and

S104. separating and removing the mold to produce the soluble needle.

As shown in FIG. 6, the method of manufacturing soluble needle in thisembodiment of the present disclosure includes firstly dissolving thewater-soluble polymers in water to prepare an aqueous water-solublepolymer solution as a molding solution. Secondly, the prepared moldingsolution is delivered into a shaping mold, wherein the shaping mold isconfigured in advance to have female mold cavities matching the shape ofthe required micro-needles 20. As a result, molding solutions deliveredinto the mold will fill into the female mold cavities. Subsequently, themolding solution is allowed to settle in the mold to shape. Since themolding solution has the property of solidifying when settledstatically, after a period of statically settling, the molding solutiongradually solidifies to shape. Lastly, soluble needle 100 could beobtained by separating the mold from the shaped molding solution.

In the method in this embodiment of the present disclosure, no specificlimitations are set to the mass fraction of the molding solution,provided that the molding solution is made from water-soluble polymersdissolved in water.

Optionally, the mass fraction of the molding solution is between 15 and25 wt %, e.g. 15 wt%, 16 wt %, 18 wt %, 20 wt %, 22 wt %, 24 wt %, or 25wt %, etc. Molding solution with mass fraction within this range is moreconvenient to handle and manufacture, produces a better shape, and iseasier to dissolve and be absorbed by the human body.

Optionally, as shown in FIG. 7, letting the molding solution settle inthe mold to shape includes:

S1031. letting the molding solution settle statically in the mold at anambient temperature of 25° C. to 70° C., and with a settling timebetween 3 h and 24 h.

The ambient temperature is set between 25° C. and 70° C., e.g. 25° C.,26° C., 30° C., 40° C., 45° C., 47° C., 50° C., 60° C., 65° C., or 70°C., etc. Providing a more suitable ambient temperature to the moldingsolution to shape could accelerate the solidification process of themolding solution, and receive better shaping effect. In addition, thesettling time is set between 3 h and 24 h, e.g. 3 h, 4 h, 8 h, 10 h, 13h, 18 h, 22 h, 23 h, 24 h, etc. Too long or too short a settling timemay cause negative effects to the applicability and reliability of thesoluble needle produced by settling the molding solution to shape.

Optionally, as shown in FIG. 8, the method further includes S201degassing treatment to the molding solution, before letting the moldingsolution settle in the mold to shape.

Performing degassing treatment to the molding solution before lettingthe molding solution settle to shape may effectively reduce the airbubbles possibly generated or trapped in the molding solution, and henceincrease the yield in manufacturing the micro-needles 20.

Optionally, as shown in FIG. 9, delivering the molding solution into amold includes:

S1021. injecting the molding solution into the mold, wherein the moldincludes a plurality of mold cavities corresponding to the plurality ofmicro-needles 20, and the volume of molding solution injected into eachmold cavity is less than the capacity of the mold cavity, so as to forma needle cavity 22 in the to-be-molded micro-needle structure in eachmold cavity.

As shown in FIG. 9, when injecting the molding solution into the mold,in order to better form the desired structure of the needle cavity 22inside the micro-needles 20, the volume of the molding solution injectedinto each mold cavity is less than the capacity of the mold cavity.Since the molding solution has a relatively high viscosity and arelatively large surface tension, it would adhere to the walls of themold cavity when injected therein and hence form a structure of needlecavity 22 in the center of each mold cavity. By adjusting the volume ofthe molding solution injected into each mold cavity, one would be ableto control and adjust the shape and size of the needle cavity 22 to someextent, so as to achieve the manufacture of the micro-needle 20 and theneedle cavity 22 within one process only.

Optionally, as shown in FIG. 10, letting the molding solution settle inthe mold to shape includes:

S1032. creating a through hole for each to-be-molded micro-needlestructure in each mold cavity, so as to form a pinhole 24 at the tips ofeach to-be-molded micro-needle structure, with the pinhole communicatingwith the needle cavities 22.

When manufacturing the micro-needles 20 configured with pinholes 24 atthe tip which are communicated with the needle cavities 22, letting themolding solution settle in the mold to shape may include creatingthrough holes for each to-be-molded micro-needle structure, so as toform the required pinholes 24 at the tips of each to-be-moldedmicro-needle structure, and allow the pinholes 24 to communicate withthe needle cavities 22.

In this process, the creation of pinholes 24 may be performed before orafter the molding solution completely solidifies by settling statically,to which this embodiment of the present disclosure does not setlimitations.

Where the above mentioned does not cover, the prior arts may apply.

Although the above terms concerning structures have been more frequentlyused, the possibility of using other terms should not be excluded. Theuse of the above terms is only for the purpose of more convenientlydescribing and explaining the essence of the present disclosure;considering them as any form of additional limitation is against thespirit of the present disclosure.

The above mentioned are merely specific embodiments of the presentdisclosure, to which the protection scope of the present disclosureshould not be limited. Any modifications or substitutions, which thoseskilled in the art can obtain without any creative work based on theembodiments of the present disclosure, should all fall within the scopeof the present disclosure. Therefore, the scope of protection of thepresent disclosure should be determined by the scope of the claims.

INDUSTRIAL APPLICABILITY

The present disclosure provides soluble needles for hair transplantationand a method of manufacturing the same. By transferring the hairfollicles to be transplanted into the soluble needles in advance, oneonly needs to control the soluble needles to penetrate the scalp andenter the dermis of the scalp during the hair transplantation surgery,which would then enable the hair follicles to survive and start to growin a relatively stable and suitable environment. This effectivelyshortens the time of the hair transplantation surgery, reduces the painof the patients, and increases the viability rate of transplanted hairfollicles and hence the success rate of hair transplantation surgery.

1. A soluble needle for hair transplantation, wherein the soluble needlecomprises a fixing plate and a plurality of micro-needles made ofwater-soluble polymers arranged on the fixing plate, wherein each ofsaid micro-needles comprises a needle wall for penetrating scalps and aneedle cavity confined by the needle wall and configured foraccommodating a hair follicle.
 2. The soluble needles as claimed inclaim 1, wherein said micro-needles are made of hyaluronic acid orpolyvinyl alcohol.
 3. The soluble needle as claimed in claim 1, whereinthe needle walls of said plurality of micro-needles are connected toeach other; or, the needle walls of said plurality of micro-needles areconnected to each other through a connecting layer and-aft theconnecting layer is made of material same as the micro-needles.
 4. Thesoluble needle according to claim 1, wherein said plurality ofmicro-needles are evenly arranged on the fixing plate.
 5. The solubleneedle as claimed in claim 4, wherein said micro-needles are arranged ata density of 20 to 40 needles/cm² on the fixing plate.
 6. The solubleneedle as claimed in claim 1, wherein micro-needles are tapered instructure.
 7. The soluble needle as claimed in claim 6, wherein a tip ofeach of the micro-needles is provided with a pinhole running through theneedle wall and communication with the needle cavity.
 8. The solubleneedle as claimed in claim 6, wherein the micro-needles are of conicalstructures, an apex angle of the micro-needles is between 15° and 20°,and a diameter of a bottom surface of the micro-needles is between 2.2mm and 2.8 mm.
 9. The soluble needle as claimed in claim 1, wherein athickness of the needle wall is between 0.8 mm and 1.2 mm.
 10. Thesoluble needle as claimed in claim 1, wherein the fixing plate is afixing film, and the fixing film is configured to be attached by themicro-needles.
 11. The soluble needle as claimed in claim 1, whereinsaid plurality of the micro-needles are configured to be fixed to saidfixing plate on a side of the needle cavities, and said fixing plate ismade of material same as the micro-needles.
 12. The soluble needle asclaimed in claim 1, wherein the micro-needles are detachably connectedto the fixing plate.
 13. A method of manufacturing a soluble needle forhair transplantation, wherein the method includes: dissolvingwater-soluble polymers in water to prepare a molding solution;delivering the molding solution into a mold; letting the moldingsolution settle in the mold to shape; and separating and removing themold to produce the soluble needle.
 14. The method as claimed in claim13, wherein a mass fraction of the molding solution is between 15 and 25wt %.
 15. The method as claimed in claim 13, wherein said letting themolding solution settle in the mold to shape includes: letting themolding solution settle statically in the mold at an ambient temperatureof 25° C. to 70° C., and with a settling time between 3 h and 24 h. 16.The method as claimed in claim 13, wherein said method includesdegassing treatment to the molding solution before said letting themolding solution settle in the mold to shape.
 17. The method as claimedin claim 13, wherein said delivering the molding solution into a moldincludes: injecting the molding solution into the mold, wherein the moldincludes a plurality of mold cavities corresponding to said plurality ofmicro-needles, and a volume of the molding solution injected into eachmold cavity is less than a capacity of the mold cavity, so as to form aneedle cavity in a to-be-molded micro-needle structure in each the moldcavities.
 18. The method as claimed in claim 17, wherein said lettingthe molding solution settle in the mold to shape includes: creating athrough hole for the each to-be-molded micro-needle structure in eachmold cavity, so as to form a pinhole at a tip of the each to-be-moldedmicro-needle structure, with the pinhole communicating with the needlecavity.
 19. The soluble needle as claimed in claim 2, wherein the needlewalls of said plurality of micro-needles are connected to each other;or, the needle walls of said plurality of micro-needles are connected toeach other through a connecting layer and the connecting layer is madeof material same as the micro-needles.
 20. The soluble needle as claimedin claim 7, wherein the micro-needles are of conical structures, an apexangle of the micro-needles is between 15° and 20°, and a diameter of abottom surface of the micro-needles is between 2.2 mm and 2.8 mm.